Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

This study has been completed.

Sponsor:

Sanofi Pasteur, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00831987

First Posted: January 29, 2009

Last Update Posted: April 14, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine

Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation

0.5 mL, Intramuscular

Other Name: Fluzone®

Experimental: Fluzone® Vaccine Group - Age ≥ 60 Years

Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine

Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation

0.5 mL, Intramuscular

Other Name: Fluzone®

Detailed Description:

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria :

Participant aged 18 years or older.

Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.

Participant is in reasonably good health as assessed by the investigator.

Participant willing and able to meet protocol requirements.

Participant willing and able to give informed consent.

Exclusion Criteria :

Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.

An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.

Self-reported history of severe adverse event to any influenza vaccine.

Vaccination against influenza in the 6 months preceding enrollment in the study.

Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.

Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.

Receipt of blood or blood products within the 3 months preceding enrollment in the study.

Diabetes mellitus requiring pharmacological control.

Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.

Person deprived of freedom by an administrative or court order (having legal or medical guardian).

For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831987